Many owner-managed specialist stores are increasingly concerned with the Medical Device Regulation (MDR) for ophthalmic optics and the Medical Device Regulation for hearing acoustics. The reason is clear. Spectacles and hearing aids are considered medical devices. They are therefore subject to strict legal requirements. And that is why opticians and hearing aid specialists are also regularly inspected.

The question often arises as to whether cleaning products for glasses and hearing aids are also covered by these regulations.

Why glasses and hearing aids fall under the MDR

The European Medical Device Regulation regulates the manufacture, distribution and use of medical devices. It is intended to ensure safety and quality.

Prescription glasses and hearing systems directly interfere with sensory perception. This is why they are legally considered medical devices. Specialist retailers must prove that they only use and sell compliant products. This is why certifications, documentation and inspections are now part of everyday life.

You can find the current MDR here

When accessories also become medical devices

Not every product in a specialist store automatically falls under the Medical Devices Ordinance. Accessories only become medical devices themselves if certain criteria are met. Three points in particular are decisive:

• The product has a medicinal or disinfectant effect
• It is technically necessary for the function of the medical device
• It actively intervenes in the safe application

If these points apply, the same strict requirements apply as for spectacles or hearing aids themselves.

Why cleaning agents are generally not covered by the MDR

In most cases, products for cleaning glasses or hearing aids are purely care and cleaning products. They do not fulfill any medical function.

As long as a cleaning agent:

• does not have a disinfecting effect
• does not have a high alcohol content
• and is not technically necessary for the use of the glasses or hearing aid

it does not fall under the Medical Device Regulation.

Glasses and hearing aids also work without special cleaning fluid. Cleaning is for comfort, everyday hygiene and durability. However, it is not a medical requirement for operation.

Significance for opticians and hearing care professionals

This differentiation is important for specialist stores. Because it means:

• No MDR certification requirement for pure cleaning agents
• No additional documentation burden
• Continued full legal certainty in sales and service

This is particularly relevant in day-to-day customer contact. After all, cleaning products are part of the standard service provided by many companies.

Conclusion on the Medical Devices Regulation in ophthalmic optics and hearing acoustics

The Medical Devices Ordinance for Ophthalmic Optics and the Medical Devices Ordinance for Hearing Acoustics concern spectacles and hearing aids themselves. Cleaning agents are generally not included.

The decisive factor is that they have no medicinal effect, are not technically necessary and do not contain any aggressive alcohol. They are then considered care products and not medical devices.

Further information on the sustainable service concept in specialist retail can be found at